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• W2749921646 abstract "2222 STATs (Signal Transducers and Activators of Transcription) are
 intracellular signaling proteins that are activated upon tyrosine
 phosphorylation and translocate from the cytosol to the nucleus where
 they bind to specific regions of DNA and exert transcriptional activity.
 STAT-3 activation has been linked to transformation and tumor
 progression in several types of cancers including Squamous Cell
 Carcinoma of the Head and Neck (SCCHN). NSC-741673, a double
 stranded oligonucleotide, is proposed for use in treating SCCHN via
 intratumoral administration. This study was conducted to provide
 the toxicity data required to support a Phase 0 clinical trial and to
 determine whether the STAT-3 activation was modulated (data not
 presented). Three study groups (two monkeys/sex/group) were
 administered (intramuscularly) vehicle or STAT-3 Decoy on
 Day 1, necropsies were performed on Days 2 and 15 (1
 monkey/sex/group/day). Dosages were 0, 0.8, and 3.2 mg/kg with a
 dose volume of 0.9 mL (flat dose). Upon observation the treated
 animals exhibited behavior that was consistent with the vehicle control
 group animals. Individual animal body weight values remained within
 1% of prestudy weights throughout the study. Increased reticulocyts
 and decreased red blood cells, hematocrit, and hemoglobin were seen
 throughout the study in all groups. These changes were not dose related
 and were attributed to the extensive blood collections throughout the
 study. Clinical chemistry fluctuations were considered normal and were
 not attributed to the test article. Based on the Bb (Complement
 activation breakdown product) levels, there was no activation of the
 alternative pathway of complement in any animal at any dose level. All
 Bb levels were within the normal range (0.17 -1.09 µg/mL). At
 necropsy, there were no gross findings attributed to STAT-3 Decoy.
 There were no microscopic findings with an exposure-related incidence
 in the routine sections. Based on these findings, the no-observable-
 adverse-effect-level (NOAEL) was greater than 3.2 mg/kg when
 administered as a single dose to male and female Cynomolgus monkeys.
 The maximum dose proposed for the Phase 0 trial is 1.0 mg.
 (supported by N01-CM42200 under the NCI RAID Program)." @default.
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• W2749921646 date "2008-05-01" @default.
• W2749921646 modified "2023-09-27" @default.
• W2749921646 title "A safety evaluation study of STAT-3 Decoy (NSC-741763) in cynomolgus monkeys" @default.
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